37402 Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Notices

Modernization Act of 1997

(Modernization Act), to reduce

unnecessary burdens for industry

without diminishing public health

protection.

DATES: Written comments may be

submitted at any time, however,

comments should be submitted by

September 8, 1998, to ensure their

adequate consideration in preparation of

the final document.

ADDRESSES: Submit written requests for

single copies of ‘‘Guidance for Industry:

For the Submission of Chemistry,

Manufacturing and Controls and

Establishment Description Information

for Human Blood and Blood

Components Intended for Transfusion

or for Further Manufacture and For the

Completion of the FDA Form 356h,

Application to Market a New Drug,

Biologic or an Antibiotic Drug for

Human Use’’ to the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

that office in processing your requests.

The draft guidance document may also

be obtained by mail by calling the CBER

Voice Information System at 1–800–

835–4709 or 301–827–1800, or by fax by

calling the FAX Information System at

1–888–CBER–FAX or 301–827–3844.

See the SUPPLEMENTARY

INFORMATION section for electronic

access to the draft guidance.

Submit written comments on the draft

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Valerie A. Butler, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a draft guidance document entitled

‘‘Guidance for Industry: For the

Submission of Chemistry,

Manufacturing and Controls and

Establishment Description Information

for Human Blood and Blood

Components Intended for Transfusion

or for Further Manufacture and For the

Completion of the FDA Form 356h,

Application to Market a New Drug,

Biologic or an Antibiotic Drug for

Human Use.’’ The draft document,

when finalized, is intended to provide

instructions on the completion of the

revised Form FDA 356h, including CMC

and establishment description sections

for human blood and blood components

intended for transfusion or for further

manufacture. In the Federal Register of

July 8, 1997 (62 FR 36558), FDA

announced the availability of a new

harmonized Form FDA 356h entitled

‘‘Application to Market a New Drug,

Biologic, or an Antibiotic for Human

Use.’’ The new harmonized form is

intended to be used by applicants for all

drug and biological products, to include

blood and blood components. The new

harmonized form when fully

implemented will allow biological

product manufacturers to submit a

single application, the BLA, instead of

two separate license application

submissions, a product license

application (PLA) and an establishment

license application (ELA).

The draft guidance document

represents the agency’s current thinking

on content and format of the CMC and

establishment description information

sections of a license application for

human blood and blood components

intended for transfusion or for further

manufacture. It does not create or confer

any rights for or on any person and does

not operate to bind FDA or the public.

An alternative approach may be used if

such approach satisfies the

requirements of the applicable statute,

regulations, or both. As with other

guidance documents, FDA does not

intend this document to be all inclusive

and cautions that not all information

may be applicable to all situations. The

document is intended to provide

information and does not set forth

requirements.

II. Requests for Comments

The draft guidance document is being

distributed for comment purposes only

and is not intended for implementation

at this time. Interested persons may

submit to the Dockets Management

Branch (address above) written

comments regarding the draft guidance

document. Written comments may be

submitted at any time, however,

comments should be submitted by

September 8, 1998, to ensure adequate

consideration in preparation of the final

document. Two copies of any comments

are to be submitted, except individuals

may submit one copy. Comments and

requests should be identified with the

docket number found in the brackets in

the heading of this document. A copy of

the draft guidance document and

received comments are available for

public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the draft guidance document

using the World Wide Web (WWW). For

WWW access, connect to CBER at

‘‘http://www.fda.gov/cber/

guidelines.htm’’.

Dated: June 30, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–18404 Filed 7–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0483]

Draft ‘‘Guidance for Industry: In the

Manufacture and Clinical Evaluation of

In Vitro Tests to Detect Nucleic Acid

Sequences of Human

Immunodeficiency Virus Type 1;’’

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance

document entitled ‘‘Guidance for

Industry: In the Manufacture and

Clinical Evaluation of In Vitro Tests to

Detect Nucleic Acid Sequences of

Human Immunodeficiency Virus Type

1.’’ The draft guidance document

addresses general and specific concerns

for gene based detection techniques, and

it is intended to provide guidance on

manufacturing and clinical trial design

issues pertaining to the validation of

tests based on nucleic acid detection

either in the presence or absence of an

amplification step.

DATES: Written comments may be

submitted at any time, however,

comments should be submitted by

October 8, 1998, to ensure their

adequate consideration in preparation of

the final document.

ADDRESSES: Submit written requests for

single copies of ‘‘Guidance for Industry:

In the Manufacture and Clinical

Evaluation of In Vitro Tests to Detect

Nucleic Acid Sequences of Human

Immunodeficiency Virus Type 1’’ to the

Office of Communication, Training and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist
Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Notices 37403

that office in processing your requests.

The draft guidance document may also

be obtained by mail by calling the CBER

Voice Information System at 1–800–

835–4709 or 301–827–1800, or by fax by

calling the FAX Information System at

1–888–CBER–FAX or 301–827–3844.

See the SUPPLEMENTARY

INFORMATION section for electronic

access to the draft guidance document.

Submit written comments on the draft

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Valerie A. Butler, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, suite 200N, Rockville,

MD 20852–1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a draft guidance document entitled

‘‘Guidance for Industry: In the

Manufacture and Clinical Evaluation of

In Vitro Tests to Detect Nucleic Acid

Sequences of Human Immunodeficiency

Virus Type 1.’’ The draft guidance

document outlines some of the major

regulatory and scientific issues

concerning gene based tests for Human

Immunodeficiency Virus (HIV), these

criteria also apply to tests for other

transfusion transmitted viruses

including Human Immunodeficiency

Virus Type 2, Hepatitis C Virus,

Hepatitis B Virus, Human T–cell

Lymphotropic Virus Types I and II.

This draft guidance document

represents the agency’s current thinking

with regard to the manufacture and

clinical evaluation of in vitro testing to

detect specific nucleic acid sequences of

HIV type 1. It does not create or confer

any rights for or on any person and does

not operate to bind FDA or the public.

An alternative approach may be used if

such approach satisfies the

requirements of the applicable statute,

regulations, or both. As with other

guidance documents, FDA does not

intend this draft guidance document to

be all-inclusive and cautions that not all

information may be applicable to all

situations. The draft guidance document

is intended to provide information and

does not set forth requirements.

II. Comments

This draft guidance document is being

distributed for comment purposes only

and is not intended for implementation

at this time. Interested persons may

submit to the Dockets Management

Branch (address above) written

comments regarding the draft guidance

document. Written comments may be

submitted at any time; however,

comments should be submitted by

October 8, 1998, to ensure adequate

consideration in preparation of the final

guidance document. Two copies of any

comments are to be submitted, except

individuals may submit one copy.

Comments should be identified with the

docket number found in brackets in the

heading of this document. A copy of the

draft guidance document and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the draft guidance document

using the World Wide Web (WWW). For

WWW access, connect to CBER at

‘‘http://www.fda.gov/cber/

guidelines.htm’’.

Dated: June 30, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–18403 Filed 7–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Submission for OMB Review

Collection; Comment Request;

Individual National Research Service

Award Application and Related Forms

Summary

Under the provisions of Section

3506(c)(2)(A) of the Paperwork

Reduction Act of 1995, the Office of

Extramural Research, the National

Institutes of Health (NIH) has submitted

to the Office of Management and Budget

(OMB) a request to review and approve

the information collection listed below.

This proposed information collection

was previously published in the Federal

Register on April 2, 1998, pages 16268–

16269 and allowed 60-days for public

comment. No public comments were

received. The purpose of this notice is

to allow an additional 30 days for public

comment. The National Institutes of

Health may not conduct or sponsor, and

the respondent is not required to

respond to, an information collection

that has been extended, revised, or

implemented on or after October 1,

1995, unless it displays a currently valid

OMB control number.

Proposed Collection

Title: Individual National Research

Service Award Application and Related

Forms. Type of Information Collection

Request: Revision, OMB 0925–0002,

Expiration Date 9/30/98. Form

Numbers: PHS 416–1, 416–9, 416–5,

416–7, 6031, 6031–1. Need and Use of

Information Collection: The PHS 416–1

and PHS 416–9 are used by individuals

to apply for direct research training

support. Awards are made to individual

applicants for specified training

proposals in biomedical and behavioral

research, selected as a result of a

national competition. The other related

forms (PHS 416–5, 416–7, 6031 and

6031–1) are used by these individuals to

activate, terminate, and provide for

payback of a National Research Service

Award. Frequency of Response:

Applicants may submit applications for

published receipt dates. If awarded,

annual progress is reported. Related

forms are used at activation,

termination, and to provide for payback

of a National Research Service Award.

Affected Public: Individuals or

Households: Business or other for-profit;

Not-for-profit institutions; Federal

Government; and State, Local or tribal

Government. Type of Respondents:

Adult scientific trainees and

professionals. The annual reporting

burden is as follows: Estimated Number

of Respondents: 29, 748; Estimated

Number of Responses per Respondent:

1.0834; Average Burden Hours Per

Responses: 2.658 hours; and Estimated

Total Annual Burden Hours Requested:

85,679. The estimated annualized cost

to respondents is $1,985,472 (Using a

$35 physician/professor average hourly

wage rate, and a $12 trainee average

hourly wage rate.) There are no Capital

Costs to report. There are no Operating

or Maintenance costs to report.

Request for Comments

Written comments and/or suggestions

from the public and affected agencies

are invited on one or more of the

following points: (1) Whether the

proposed collection of information is

necessary for the proper performance of

the function of the agency, including

whether the information will have

practical utility; (2) The accuracy of the

agency’s estimate of the burden of the

proposed collection of information,

including the validity of the

methodology and assumptions used; (3)

Ways to enhance the quality, utility, and

clarity of the information to be

collected; and (4) Ways to minimize the

burden of the collection of information

on those who are to respond, including

the use of appropriate automated,